An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria (BEFLEX)
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|ClinicalTrials.gov Identifier: NCT01557283|
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : June 30, 2014
Last Update Posted : June 30, 2014
With the new reimbursement criteria, we want:
To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year.
To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment
|Condition or disease||Intervention/treatment|
|Plaque Psoriasis Patients||Other: Enbrel treatment|
|Study Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria - Beflex Study|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Plaque psoriasis patients
Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria
Other: Enbrel treatment
Enbrel SC 50mg once weekly or 25mg twice weekly
- Number of Weeks of Etanercept Treatment [ Time Frame: Baseline up to end of study (90 weeks) ]Average duration of time in weeks for treatment with etanercept was reported.
- Number of Weeks of Off-Treatment [ Time Frame: Baseline up to end of study (90 weeks) ]Total duration of time in weeks for which participants discontinued etanercept treatment was reported.
- Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Start and end of cycle 1, 2, 3 ]Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
- Percentage of Body Surface Area (BSA) Affected by Psoriasis [ Time Frame: Start and end of cycle 1, 2, 3 ]Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.
- Number of Participants With Reasons for Treatmant Discontinuation [ Time Frame: Baseline up to end of study (90 weeks) ]Number of participants who discontinued etanercept before completing the study was reported.
- Number of Participants Who Received Continuous Treatment [ Time Frame: Baseline up to end of study (90 weeks) ]Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported.
- Number of Participants Who Received Intermittent Treatment [ Time Frame: Baseline up to end of study (90 weeks) ]Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557283
|Leuven, Belgium, 3000|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|